FDA.reportPublic FDA data

CareSuperb COVID-19 Antigen Test

Primary DI
00850010224480
Brand
CareSuperb COVID-19 Antigen Test
Company
Access Bio Inc.
Model
RCXM-02071
Published
2026-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
QYTOver-The-Counter Covid-19 Antigen Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QYTOver-The-Counter Covid-19 Antigen TestMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241915000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241915000CareSuperb™ COVID-19 Antigen Home TestAccess Bio, Inc.2025-01-29QYT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850010224480PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010224480008500102244808500102244800850010224480

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testingA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment.

Regulatory Flags#

DUNS number
116671434
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850010224497CareSuperb COVID-19 Antigen External ControlSCXM-001712026-10-01
00850010224442CareSuperb COVID-19/FluA&B Antigen Combo TestRCNM-020712026-06-08
00850010224459CareSuperb COVID-19/Flu A&B Antigen Combo External ControlSCNM-001712026-06-08
00850010224275CareSuperb COVID-19 Antigen Home TestRCTM-001712026-01-05
00850010224305CareSuperb COVID-19 Antigen Home TestRCTM-002712026-01-05
00850010224435CareSuperb COVID-19 Antigen Home TestRCTM-005712026-01-05
00850010224381CareSuperb COVID-19/FluA&B Antigen Combo Home TestRCUM-005712025-12-24
00850010224350CareSuperb COVID-19/FluA&B Antigen Combo HomeTestRCUM-001712025-09-30
00850010224367CareSuperb COVID-19/FluA&B Antigen Combo HomeTestRCUM-002712025-09-30
00850010224374CareSuperb COVID-19/FluA&B Antigen Combo HomeTestRCUM-020712025-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00311917080062WalgreensWALGREEN CO.QYT2026-08-26
50850078377369iHealthiHealth Labs Inc.QYT2026-07-21
00682607002306Flowflex COVID-19 Antigen Home TestAcon Laboratories, Inc.QYT2026-01-26
20682607660265Flowflex COVID-19 Antigen Home TestAcon Laboratories, Inc.QYT2026-01-26
00810143620122GenaCheck® COVID-19 Rapid Self-Test 2TGenabio Diagnostics Inc.QYT2026-01-21
00810143620382GenaCheck® COVID-19 Rapid Self-Test 20TGenabio Diagnostics Inc.QYT2026-01-21
00810143620399GenaCheck® COVID-19 Rapid Self-Test 4TGenabio Diagnostics Inc.QYT2026-01-21
B379C19S21COVID-19 Detect™ Rapid Self -TestINBIOS INTERNATIONAL, INCQYT2026-01-16
00850010224275CareSuperb COVID-19 Antigen Home TestAccess Bio Inc.QYT2026-01-05
00850010224305CareSuperb COVID-19 Antigen Home TestAccess Bio Inc.QYT2026-01-05
00850010224435CareSuperb COVID-19 Antigen Home TestAccess Bio Inc.QYT2026-01-05
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00816862027402WELLlife™ WONDFO USA CO., LTD.QYT2025-07-03
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10816862027287WELLlife™ WONDFO USA CO., LTD.QYT2025-05-16
06930251802365equateWAL-MART STORES, INC.QYT2025-04-05
16930251802362equateWAL-MART STORES, INC.QYT2025-04-05
00816862026252WELLlife™ WONDFO USA CO., LTD.QYT2024-12-20
00816862026276WELLlife™ WONDFO USA CO., LTD.QYT2024-12-20
00816862026290WELLlife™ WONDFO USA CO., LTD.QYT2024-12-20
10816862026259WELLlife™ WONDFO USA CO., LTD.QYT2024-12-20
10816862026273WELLlife™ WONDFO USA CO., LTD.QYT2024-12-20
10816862026297WELLlife™ WONDFO USA CO., LTD.QYT2024-12-20
00816862026238WELLlife™ WONDFO USA CO., LTD.QYT2024-11-22
00816862026177WELLlife™ WONDFO USA CO., LTD.QYT2024-11-22
10816862026235WELLlife™ WONDFO USA CO., LTD.QYT2024-11-22
30014613340188CVS Health At Home COVID-19 Test KitDIAGNOSTIC HYBRIDS, INC.QYT2024-11-20